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BD (Becton, Dickinson and Company) Regulatory Affairs Specialist in San Jose, California

Job Description Summary

Job Description

Be part of something bigger!

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

The Regulatory Affairs Specialist is responsible for supporting a variety of regulatory activities and projects with oversight from senior regulatory staff. This includes tasks and deliverables such as regulatory assessment for product changes, regulatory strategy, U.S./EU product submissions, registration file maintenance and organization, and other related activities.

Activities include but are not limited to the following:

  • Represents RA in new product development team(s). Responsible for completion of RA strategy, review and approval of design control related documents.

  • Supports preparation of 510(k)s and/or Technical Files

  • For changes to products and processes, conducts regulatory assessments, authors and maintains Letters to File, and tech files updates.

  • Works will entail problems of moderate complexity and diverse scope, including investigation, data analysis and ownership of task execution and completion.

  • Assists in implementing department procedures and maintaining regulatory requirements.

  • Provides support to Sr. RA manager, and performs other related duties and assignments as required.

Minimum Qualifications:

  • Minimum of 2 year experience working in a medical regulated environment

  • Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices. This includes analytical problem solving

  • Ability to handle multiple tasks and to prioritize and schedule work to meet business needs.

  • Ability to identify areas of concern in complex projects and manage changes.

  • Demonstrated organizational and planning skills, including process savvy, action oriented, focused urgency and driving for results

  • Excellent team skills with ability to influence others without authority.

  • Excellent communication and interpersonal skills, ability to communicate and work in a diverse team environment; effective interactions with technical personnel (scientific and legal). This includes excellent written and verbal communication skills

  • Ability to write high quality submission documentation

  • Computer literacy (SAP, Microsoft Word / Excel / PowerPoint)

  • Detail oriented, with emphasis on accuracy and completeness

Education and Experience:

  • B.S. degree in health science or life science field (biomedical engineering, engineering, computer science, biology, medical technology, etc.). RAC Certification a plus.

  • Minimum of 1 year’s experience working in an U.S. FDA/ or ISO regulated environment.

  • IVD experience a plus.

Why join us?

A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.

To learn more about BD visit https://jobs.bd.com/

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Primary Work Location

USA CA - San Jose

Additional Locations

Work Shift

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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